Prucalopride succinate

Orange BookUNIISPLATC A06AX05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSomerset Therapeutics, LLC

CountryUS (United States)

ATC codeA06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7006982101
1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

4V2G75E1CK

PRUCALOPRIDE SUCCINATE

RxCUI 2107309

Orange Book

A219078

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4V2G75E1CK",
    "rxcui": "2107309",
    "inchikey": "QZRSNVSQLGRAID-UHFFFAOYSA-N",
    "display_name": "PRUCALOPRIDE SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "af559917-802b-486c-9f7b-b770115acac8": {
      "match": "brand_token",
      "title": "PRUCALOPRIDE TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]",
      "spl_version": "1",
      "published_date": "2026-02-02"
    }
  },
  "productid": "70069-821_7b3acc62-d656-47b8-91d2-5b30cd699fbd",
  "productndc": "70069-821",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219078",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jun 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jun 24, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRUCALOPRIDE SUCCINATE",
  "proprietary_name": "Prucalopride succinate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219078",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prucalopride succinate",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "1"
}

Related drugs

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